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Symbio Generics Strengthens Quality Framework with New Executive Hire at Jigani R&D Hub
JIGANI – In a strategic move to bolster its quality and compliance capabilities, Symbio Generics, a player in the pharmaceutical manufacturing sector, has announced an opening for an Executive in Quality Assurance. The position is based at the company’s Research and Development facility in Jigani, underscoring the critical link between R&D innovation and robust quality systems.
The new role is designed for a seasoned quality professional with a background in Active Pharmaceutical Ingredients (APIs), reflecting the industry’s heightened focus on supply chain integrity and regulatory excellence.
A Deep Dive into the Role
The Executive – Quality Assurance will operate as a key support to the Head of QA, taking on a hands-on role in maintaining and enhancing the company’s quality standards. The position demands a candidate with 2 to 5 years of specific experience in a QA function within the API pharmaceutical space, coupled with a Master of Science degree in Chemistry.
The job description outlines a comprehensive set of responsibilities central to pharmaceutical compliance:
· Documentation Leadership: The executive will be tasked with the preparation of Standard Operating Procedures (SOPs) and the management of the document control system, forming the foundational framework for all quality processes.
· Supply Chain Vigilance: A critical function will be the review of vendor documents for Key Starting Materials (KSMs), raw materials, APIs, and excipients, ensuring that all incoming materials meet stringent quality specifications.
· Quality System Management: The role involves a thorough review of QMS (Quality Management System) documents and contract laboratory paperwork, ensuring external partners align with Symbio’s quality expectations.
· Audit and Continuous Improvement: The candidate will prepare detailed audit reports and review CAPA (Corrective and Preventive Action) plans, driving continuous improvement and regulatory adherence. Additional duties include reviewing plant documents, Batch Manufacturing Records (BMRs), and various operational logs.
The company has highlighted Vendor Qualification and QMS activities as primary areas of expertise for the ideal candidate, pointing to a strategic emphasis on strengthening these core pillars of pharmaceutical quality assurance.
Industry Context and Opportunity
This recruitment drive comes at a time when India’s API sector is experiencing significant growth and increased regulatory scrutiny. For professionals, a role that offers responsibility across such a wide spectrum of QA activities—from vendor management to audit processes—represents a substantial career advancement opportunity.
“Roles like this are crucial,” an industry analyst commented. “They bridge the gap between R&D and commercial manufacturing, ensuring that quality is built into products from the very beginning. It signals that Symbio Generics is investing seriously in its quality infrastructure to support its R&D ambitions.”
Interested and qualified candidates are encouraged to submit their CV and portfolio to careers@symbiogenerics.com
FAQ:
1. What specific types of documents will the QA Executive be responsible for reviewing and controlling?
Answer:
The QA Executive will manage and review key quality documentation including Standard Operating Procedures (SOPs), Batch Manufacturing Records (BMRs), Quality Management System (QMS) documents, audit reports, CAPA records, and vendor qualification files. The role also includes maintaining document control systems to ensure traceability, version control, and compliance with regulatory standards like ICH Q7 and WHO GMP.
2. What are the key steps involved in Vendor Qualification and how does QA contribute to this process?
Answer:
Vendor Qualification involves assessing and approving suppliers of KSMs, raw materials, intermediates, and APIs. The QA Executive’s role includes:
Reviewing vendor questionnaires and technical documentation (CoAs, DMFs, etc.).
Conducting or supporting vendor audits to assess compliance with GMP and regulatory requirements.
Evaluating trial batches or sample analysis reports.
Maintaining an approved vendor list (AVL) and tracking performance through periodic re-evaluation.
3. How does the QA Executive ensure effective CAPA implementation after internal or external audits?
Answer:
Post-audit, the QA Executive reviews all non-conformities, assists in root cause analysis (RCA), and ensures CAPA plans are drafted with realistic timelines and measurable outcomes. The executive then verifies completion of CAPA actions, monitors their effectiveness through trend analysis, and documents closure reports in alignment with QMS procedures.
4. What role does QA play in managing Quality Management System (QMS) activities at the R&D site?
Answer:
The QA Executive oversees QMS documentation and workflows including deviation management, change control, OOS/OOT investigations, and risk assessments. They ensure that QMS processes are followed across R&D operations and that learnings are shared with the manufacturing QA team for harmonization. The role also involves periodic QMS reviews and supporting audits for compliance readiness.
5. What are the key regulatory and GMP guidelines relevant to QA activities in API R&D operations?
Answer:
The QA Executive must have working knowledge of key regulatory and quality frameworks such as:
ICH Q7 – Good Manufacturing Practice for Active Pharmaceutical Ingredients.
WHO TRS 986 Annex 2 – GMP for APIs.
Schedule M (Drugs and Cosmetics Rules, India) – Good Manufacturing Practices.
21 CFR Part 211 – U.S. FDA GMP regulations.
EU GMP Part II – Basic requirements for APIs.
Familiarity with these standards ensures that R&D activities and vendor interactions meet both domestic and international compliance expectations.
